ABSTRACT
In 2019, Germany passed the Digital Healthcare Act, which, among other things, created a "Fast-Track" regulatory and reimbursement pathway for digital health applications in the German market. The pathway explicitly provides for flexibility in how researchers can present evidence for new digital products, including the use of real-world data and real-world evidence. Against this backdrop, the Digital Medicine Society and the Health Innovation Hub of the German Federal Ministry of Health convened a set of roundtable discussions to bring together international experts in evidence generation for digital medicine products. This Viewpoint highlights findings from these discussions with the aims of (1) accelerating and stimulating innovative approaches to digital medical product evaluation, and (2) promoting international harmonisation of best evidentiary practices. Advancing these topics and fostering international agreement on evaluation approaches will be vital to the safe, effective, and evidence-based deployment and acceptance of digital health applications globally.
Subject(s)
Delivery of Health Care , Health Facilities , GermanyABSTRACT
Due to the rapidly advancing digitalization, healthcare will also change significantly in the next few years. For example, in Germany, new legal framework conditions have already set the course for the electronic patient record (ePA), the eprescription, and the integration of digital health applications (DiGA). The new fast-track procedure of the Federal Institute for Drugs and Medical Devices (BfArM) for evaluating the reimbursability of DiGA is an important step that will be followed by others in the coming years.This article uses a future scenario for the year 2030 to describe the legal, technical, and practical changes that could occur by then. In 2030, healthcare could be organized in individual and integrated treatment pathways that offer comprehensive support to the insured. Interoperable digital components could, for example, make structured data available for research purposes. Doubts concerning data protection could become a thing of the past if data protection law is reformed and harmonized and new consent procedures for patients are developed. New professional fields could become established and market access for innovative digital medical products could be further improved.Another important aspect that can help to exploit the potential of digital healthcare is the creation of a European data space based on a technical infrastructure that upholds high ethical and social standards. Active measures on the part of legislators can create the necessary conditions for innovations to be incorporated into the system for the benefit of patients and for the German healthcare system to be able to cope with the ongoing changes in medical technology.
